Esthetic apparatus useful for increasing skin rejuvenation and methods thereof

ABSTRACT

The present invention provides a system for increasing skin rejuvenation of a region of a patient&#39;s skin comprising a pulsed electromagnetic field (PEMF) frequency generator for constantly providing electromagnetic pulses to the region of a patient&#39;s skin and a deep tissue diathermy device for constantly applying heat to the region of a patient&#39;s skin up to temperature T. The system is adapted for simultaneously applying heat and PEMF to the region of a patient&#39;s skin; wherein application of the system increases skin rejuvenation such that the skin rejuvenation increase (SRI) is greater than the sum of the SRI provided by electromagnetic pulses increase and the SRI provided by the deep tissue diathermy device increase.

FIELD OF THE INVENTION

This invention generally relates to an esthetic device used to improveskin viability and skin rejuvenation, and a method of using the device.

BACKGROUND OF THE INVENTION

Improving the appearance of the skin has been the goal of many estheticproducts and procedures for many years, since a tight skin, withoutwrinkles or cellulite, has a younger and more appealing appearance.Apart from age related changes, the skin also suffers from exposure tochemical and physical injuries, such as tobacco, cosmetics, estheticsand radiation from the sun and other sources. Those factors contributeto the decrease in collagen production, to reduced elasticity, and theappearance of wrinkles.

A few main approaches to tightening of the skin are common practicetoday. The surgical approach carries disadvantages related to theanesthesia, the surgical complications, and the healing process, whichmay cause scars. The chemical peel approach usually involves injury tothe outermost layer of the skin—the epidermis—which may causediscoloration. Since collagen fibers are found in the dermis—thesubcutaneous layer of the skin, and since heat was shown to contractthese fibers and generate their production [Zelickson B D, Kist D,Bernstein E, Brown D B, Ksenzenko S, Burns J, Kilmer S, Mehregan D, PopeK. Histological and ultrastructural evaluation of the effects of aradiofrequency-based nonablative dermal remodeling device: a pilotstudy. Arch Dermatol. 2004 February; 140(2):204-9], methods ofdifferentially heating the dermis (deep tissue diathermy) have recentlyarisen.

A unique method of treating the dermis is called Pulsed ElectromagneticFields (PEMF) therapy. This method usually employs electromagneticradiation of different frequencies—ranging from static magnetic fields,through extremely low frequencies (ELF) to higher radiofrequencies(RF)—administered in pulses.

PEMF works in few ways. Due to the radiation absorbed in the tissue, itcan be heated to various temperatures, depending on the power applied,the frequency transmitted, and more importantly the tissuecharacteristics. Eventually, the tissue can be warmed to denaturationtemperatures, which cause coagulation necrosis and tissue damage. It canalso be heated to lower temperatures, which proved to result in theafore-mentioned contraction of collagen fibers.

Another modus operandi involves non thermal effects. These rely onspecific tissue components and their reaction to the applied radiationcharacteristics. These effects might be due to large charged moleculesand their reaction to various frequencies and frequency harmonies,charged small ions in the cell membranes affecting the cells functionand reactions to hormones and chemical signals, charged small ions inthe extracellular space and other poorly understood mechanisms.

Furthermore, applying the radiation in pulses was also found to have nonthermal effects. Yet more, only a specific combination of frequency,duty cycle and transmitted power achieve a specific tissue response.Recent scientific research has confronted these challenges and found thePEMF characteristics needed for the desired biophysical response.

It is now commonly accepted that weak electromagnetic fields (EMF)administered in pulses are capable of initiating various healingprocesses in fractures, multiple sclerosis and Parkinson's disease, andeven delivering pain relief; however it seems that most of theconditions that seem most likely to respond to PEMF are musculoskeletal.The FDA has allowed the use of pulsed radiofrequency electromagneticfield for treatment of pain and edema in superficial soft tissues twodecades ago. [Rosch, P. J., Markov, M. S., eds. BioelectromagneticMedicine, Marcel Dekker, NY, 251-264].

The use of PEMF can also be recruited for cosmetic purposes as describedabove. Several studies have addressed the effect of PEMF on dermalcomponents. For example, in vivo trials showed that pulsedelectromagnetic field of certain field intensities and frequenciesincreased epidermal collagen synthesis [Ahmadian S, Zarchi S R, BolouriB. Effects of extremely-low-frequency pulsed electromagnetic fields oncollagen synthesis in rat skin. Biotechnol Appl Biochem. 2006 Feb; 43(Pt2):71-5]. This new formed collagen increases skin elasticity andrejuvenates its appearance.

In vitro trials showed that PEMF increased the degree of endothelialcell tubulization and proliferation, and augmented angiogenesisprimarily by stimulating endothelial release of FGF-2, inducingparacrine and autocrine changes in the surrounding tissue [Tepper O M etal. Electromagnetic fields increase in vitro and in vivo angiogenesisthrough endothelial release of FGF-2. FASEB J. 2004 August;18(11):1231-3. Epub 2004 Jun. 18]. Angiogenesis, the sprouting of newblood vessels, increases blood flow to the tissue, which in turnincreases oxygen and nutritional substances delivery to the tissue. Thiseffect is most beneficial for an injured tissue, promoting rapid andimproved healing. The growth factor released further enhances thehealing process, both in quality and time of improvement.

The scientific evidence of the effect of PEMF on tissues was utilized invarious applications. For example, US20050182462A1 discloses healthydeep tissue heating using PEMF for the purpose of causing contractionand tightening of the skin.

PEMF has also been used to improve skin wound healing. For example,WO08064272 discloses a method of treating a severe diabetic ulcer usingPEMF. The patent also discloses the addition of intermittent compressiontherapy (ICT) and the use of low intensity ultrasound (up to 50 W/cm²),the latter aimed at inhibiting microbial growth.

Other methods of heating the dermis used non pulsating RF radiation,applied by antenna or electrodes. For example, WO98005380 discloses amethod of tightening skin using an RF electromagnetic energy deliverydevice.

Improving the results of skin tightening based on dermis diathermy isstill a long felt need, both for esthetic and therapeutic purposes.

SUMMARY OF THE INVENTION

It is one object of the present invention to provide a system (10)adapted to increase skin rejuvenation of a region of a patient's skin,said system comprising

-   -   a. a pulsed electromagnetic field (PEMF) frequency generator (2)        for constantly providing electromagnetic pulses to said region        of a patient's skin; and,    -   b. a deep tissue diathermy device (4) for constantly applying        heat to said region of a patient's skin up to temperature T;        said system (10) is adapted for simultaneously applying heat and        PEMF to said region of a patient's skin; wherein application of        said system increases said skin rejuvenation such that said skin        rejuvenation increase (SRI) is greater than the sum of said SRI        provided by electromagnetic pulses increase and said SRI        provided by said deep tissue diathermy device increase.

It is another object of the present invention to provide the system asdefined above, wherein said electromagnetic pulse is a triangular shapedat frequency of 25 Hz and intensity of 20 Gauss.

It is another object of the present invention to provide the system asdefined above, wherein said electromagnetic pulse is square shaped at afrequency of 16 Hz, duration of about 5 milliseconds and intensity of 12Gauss.

It is another object of the present invention to provide the system asdefined above, wherein said deep tissue diathermy device (4) is selectedfrom any device emitting RF radiation or any means adapted for producingelectrical current absorbed by subcutaneous tissue.

It is another object of the present invention to provide the system asdefined above, wherein said deep tissue diathermy device (4)additionally comprises:

-   -   a. at least one electrical output device adapted to generate RF        electromagnetic energy;    -   b. at least two electrodes electrically coupled to said        electrical output device and placed on said skin region, wherein        all said electrodes are adapted to simultaneously apply said RF        energy to said skin region.

It is another object of the present invention to provide the system asdefined above, wherein said deep tissue diathermy device (4)additionally comprises:

-   -   a. at least one electrical output device adapted to generate        electrical current;    -   b. at least two electrodes electrically coupled to said        electrical output device and placed on said skin region, wherein        all said electrodes are adapted to simultaneously apply said        electrical current to said skin region.

It is another object of the present invention to provide the system asdefined above, wherein said system reduces side effects and/or harmfuleffects of said electromagnetic pulses and/or said deep tissue diathermysuch that said reduction of said side effects and/or said harmfuleffects is greater than the sum of said reduction of saidelectromagnetic pulses and/or said reduction of said deep tissuediathermy.

It is another object of the present invention to provide the system asdefined above, wherein said system additionally comprising a controlsystem (6) adapted to regulate said electromagnetic pulses and/or saiddeep-tissue diathermy.

It is another object of the present invention to provide the system asdefined above, wherein said pulsed electromagnetic frequency generatoris adapted to provide a dynamic magnetic field such that saidelectromagnetic pulses vary with time.

It is another object of the present invention to provide the system asdefined above, wherein the shape of said electromagnetic pulse isselected in a non-limiting manner from a group consisting of squarewave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spikedwave or any other mathematical combination.

It is another object of the present invention to provide the system asdefined above, wherein the magnetic field intensity B of each pulseapplied by said pulsed electromagnetic frequency generator (2) rangesbetween about 0 and about 3 Tesla.

It is another object of the present invention to provide the system asdefined above, wherein the duration of each pulse applied by said pulsedelectromagnetic frequency generator (2) ranges between about 3 and about1000 milliseconds.

It is another object of the present invention to provide the system asdefined above, wherein the frequency F applied by the pulses of saidpulsed electromagnetic frequency generator (2) ranges between about 1 Hzand about 1M Hz.

It is another object of the present invention to provide the system asdefined above, wherein the energy E applied by the pulses of said pulsedelectromagnetic frequency generator (2) ranges between about 1 and about150 watts per pulse.

It is another object of the present invention to provide the system asdefined above, wherein said deep tissue diathermy device (4) is selectedin a non-limiting manner from a group consisting of an ultrasonicdiathermy, an optical device, electromagnetic induction, sound wavesemitting instrument, direct heat applying instrument, or from any othermeans of heating subcutaneous tissue to temperature T.

It is another object of the present invention to provide the system asdefined above, wherein said optical device is adapted to emit light inwavelengths absorbed by subcutaneous tissue such that said subcutaneoustissue is heated.

It is another object of the present invention to provide the system asdefined above, wherein said sound waves emitting instrument is adaptedto emit sound waves absorbed by the subcutaneous tissue such that saidsubcutaneous tissue is heated.

It is another object of the present invention to provide the system asdefined above, wherein said temperature T is higher than about 30 andlower than about 80 degrees.

It is another object of the present invention to provide the system asdefined above, wherein said power supply and control system (6) monitorsphysical tissue parameters and changes applied heat and electromagneticpulses accordingly.

It is another object of the present invention to provide the system asdefined above, wherein said power supply and control system (6)additionally comprising:

-   -   a. processing means, adapted to store in a communicable database        predetermined parameters defining (i) safe treatment parameters        and (ii) unsafe treatment parameters; said parameters are        selected from a group consisting of time t of said treatment,        temperature T of said tissue, ratio t/T, Frequency F, power P,        energy E applied by the pulses of said pulsed electromagnetic        frequency generator, depth D of said treated tissue, magnetic        field intensity B, tissue impedance, specific absorption rate        (SAR), treatment depth, superficial muscle contractions or a        combination thereof;    -   b. sensing means; adapted to sense electromagnetic radiation and        heat radiation parameters selected from a group consisting of        time t of time t of said treatment, temperature T of said        tissue, ratio t/T, Frequency F, power P, Intensity I of said        ultrasound irradiation, energy E applied by the pulses of said        pulsed electromagnetic frequency generator, depth D of said        treated tissue, magnetic field intensity B, tissue impedance,        specific absorption rate (SAR), treatment depth, superficial        muscle contractions or a combination thereof;    -   c. regulating means, adapted to allow said electromagnetic        radiation and heat radiation if said parameters are within said        safe treatment parameters and to stop the electromagnetic        radiation if the radiation parameters are in said unsafe        treatment parameters.

It is another object of the present invention to provide the system asdefined above, wherein said power supply and control system (6) includesa mechanism for skin cooling.

It is another object of the present invention to provide the system asdefined above, wherein said system (10) is encased in at least oneplatform.

It is another object of the present invention to provide the system asdefined above, wherein said pulsed electromagnetic frequency generator(2) and said deep tissue diathermy device (4) have more than oneapplicator to treat more than one body part simultaneously.

It is another object of the present invention to provide the system asdefined above, wherein said pulsed electromagnetic frequency generator(2) has electrostatic shielding.

It is another object of the present invention to provide the system asdefined above, especially adapted to increase skin rejuvenation in theimmediate (short) range.

It is another object of the present invention to provide the system asdefined above, especially adapted to increase skin rejuvenation in theintermediate range.

It is another object of the present invention to provide the system asdefined above, especially adapted to increase skin rejuvenation in thelong range.

It is another object of the present invention to provide the system asdefined above, wherein said system is especially adapted to operateaccording to IEC selected from a group consisting of IEC 60601-2-35, IEC60601-2-33, IEC 60601-2-29, IEC 60601-2-9, IEC 60601-2-5, IEC 60601-2-3,IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601-1-3, IEC60601-1-2, IEC 60601-1-1 or any combination thereof.

It is another object of the present invention to provide a method (400)of increasing skin rejuvenation of a region of a patient's skin. Themethod comprises steps selected inter alia from:

-   -   a. obtaining (i) pulsed electromagnetic frequency generator;        and, (ii) a deep tissue diathermy device;    -   b. applying heat to a subcutaneous tissue within said region up        to temperature T; and,    -   c. applying pulses of electromagnetic field to said region;        wherein said increasing of said skin rejuvenation is greater        than the sum of said applying heat to a subcutaneous tissue        within said region increase and said applying pulses        electromagnetic therapy to said region increase.

It is another object of the present invention to provide a method (410)of increasing skin rejuvenation of a region of a patient's skin. Themethod comprises steps selected inter alia from:

-   -   a. obtaining (i) pulsed electromagnetic frequency generator;        and, (ii) a deep tissue diathermy device;    -   b. applying pulses of electromagnetic field to said region; and,    -   c. applying heat to a subcutaneous tissue within said region up        to temperature T;        wherein said increasing of said skin rejuvenation is greater        than the sum of said applying heat to a subcutaneous tissue        within said region and said applying pulses electromagnetic        therapy to said region

It is another object of the present invention to provide a method (420)of increasing skin rejuvenation of a region of a patient's skin. Themethod comprises steps selected inter alia from:

-   -   a. obtaining (i) pulsed electromagnetic frequency generator;        and, (ii) a deep tissue diathermy device;    -   b. applying heat to a subcutaneous tissue within said region up        to temperature T;        whilst simultaneously applying pulses of electromagnetic field        to said region; wherein said increasing of said skin        rejuvenation is greater than the sum of said applying heat to a        subcutaneous tissue within said region and said applying pulses        electromagnetic therapy to said region.

It is another object of the present invention to provide the methods asdefined above, wherein said system reduces side effects and/or harmfuleffects of said electromagnetic pulses and/or said deep tissue diathermysuch that said reduction of said side effects and/or said harmfuleffects is greater than the sum of said reduction of saidelectromagnetic pulses and/or said reduction of said deep tissuediathermy.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of monitoring and/orcontrolling said steps of applying heat to a subcutaneous tissue withinsaid region and/or said step of applying pulsed electromagnetic therapyto said region.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of applying a dynamicmagnetic field onto said region.

It is another object of the present invention to provide the methods asdefined above, additionally comprising steps of

-   -   a. storing in a communicable database predetermined parameters        defining (i) safe treatment parameters and (ii) unsafe treatment        parameters; said parameters are selected from a group consisting        of time t of said treatment, temperature T of said tissue, ratio        t/T, Frequency F, power P, energy E applied by the pulses of        said pulsed electromagnetic frequency generator, depth D of said        treated tissue, magnetic field intensity B, tissue impedance,        specific absorption rate (SAR), treatment depth, superficial        muscle contractions or a combination thereof;    -   b. sensing electromagnetic radiation and heat radiation        parameters selected from a group consisting of time t of said        treatment, temperature T of said tissue, ratio t/T, Frequency F,        power P, Intensity I of said ultrasound irradiation, energy E        applied by the pulses of said pulsed electromagnetic frequency        generator, depth D of said treated tissue, magnetic field        intensity B, tissue impedance, specific absorption rate (SAR),        treatment depth, superficial muscle contractions or a        combination thereof;    -   c. allowing said electromagnetic radiation and said heat        radiation if parameters within said safe treatment parameters        and to stop the electromagnetic radiation if the radiation        parameters are in said unsafe treatment parameters.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting the shape ofsaid electromagnetic pulse is selected in a non-limiting manner from agroup consisting of square wave, a sine wave, a triangular wave,sawtooth wave, ramp waves, spiked wave or any other mathematicalcombination.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of applying a triangularshaped electromagnetic pulse at frequency of 25 Hz and intensity of 20Gauss.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of applying a square shapedelectromagnetic pulse at a frequency of 16 Hz, duration of about 5milliseconds and intensity of 12 Gauss.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting said deeptissue diathermy device (4) from any device emitting RF radiation or anymeans adapted for producing electrical current absorbed by subcutaneoustissue.

It is another object of the present invention to provide the methods asdefined above, wherein said step of applying heat to a subcutaneoustissue additionally comprising steps of

-   -   a. obtaining at least one electrical output device adapted to        generate RF electromagnetic energy;    -   b. electrically coupling at least two electrodes to said        electrical output device;    -   c. placing said at least two electrodes on said skin region;        and,    -   d. simultaneously applying via all said electrodes said RF        energy to said skin region.

It is another object of the present invention to provide the methods asdefined above, wherein said step of applying heat to a subcutaneoustissue additionally comprising steps of

-   -   a. obtaining at least one at least one electrical output device        adapted to generate electrical current;    -   a. electrically coupling at least two electrodes to said        electrical output device;    -   b. placing said at least two electrodes on said skin region;        and,    -   c. simultaneously applying via all said electrodes said        electrical current to said skin region.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting saidtemperature T from a region of about 30 to about 80 degrees.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting the duration ofeach pulse applied by said pulsed electromagnetic frequency generator(2) to be higher than about 3 and lower than about 1000 milliseconds.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting the magneticfield intensity B of each pulse applied by said step of applying pulsedelectromagnetic therapy to said region to be higher than about 0 andlower than about max magnetic field used in MRI devices (i.e., 3 Tesla).

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting the frequency Fapplied by the pulses applied by said step of applying pulsedelectromagnetic therapy to said region to be higher than about 1 andlower than about 1M Hz.

It is another object of the present invention to provide the methods asdefined above, additionally comprising step of selecting the energy Eapplied by said step of applying pulsed electromagnetic therapy to saidregion to be higher than about 1 and lower than about 150 watts perpulse.

It is another object of the present invention to provide the methods asdefined above, wherein step of applying heat is applied for about 0.01to 60 minutes.

It is another object of the present invention to provide the methods asdefined above, wherein the heat and the pulsed electromagnetic therapyare applied simultaneously, sequentially or separately.

It is another object of the present invention to provide the methods asdefined above, wherein said method is repeated 1 to 100 times in eachtreatment.

It is another object of the present invention to provide the methods asdefined above, wherein said treatment is repeated more than once.

It is another object of the present invention to provide the methods asdefined above, wherein said step of applying heat is performed bydevices selected from a group consisting of: ultrasonic diathermy, anoptical device, electromagnetic induction, sound waves emittinginstrument, direct heat applying instrument, or from any other means ofheating subcutaneous tissue to temperature T.

It is another object of the present invention to provide the methods asdefined above, especially adapted to increase skin rejuvenation in theimmediate (short) range

It is another object of the present invention to provide the methods asdefined above, especially adapted to increase skin rejuvenation in theintermediate range.

It is another object of the present invention to provide the methods asdefined above, especially adapted to increase skin rejuvenation in thelong range.

It is another object of the present invention to provide the methods asdefined above, wherein said method is especially adapted to operateaccording to IEC selected from a group consisting of IEC 60601-2-35, IEC60601-2-33, IEC 60601-2-29, IEC 60601-2-9, IEC 60601-2-5, IEC 60601-2-3,IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601-1-3, IEC60601-1-2, IEC 60601-1-1 or any combination thereof.

It is another object of the present invention to provide an integratedsystem (20) adapted to increase skin rejuvenation of a region of apatient's skin, said system comprising at least two electrodes (41)adapted to be placed on said region of a patient's skin; each of saidelectrodes is at least partially coiled via a coil 42; wherein each ofsaid electrodes is adapted for both (i) providing electromagnetic pulsesto said region of a patient's skin; and, (ii) applying heat up totemperature T to said region of a patient's skin; further wherein all ofsaid electrodes are adapted to simultaneously provide saidelectromagnetic pulses to said region of a patient's skin and apply heatto said region of a patient's skin.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said heat applied to said region of apatient's skin is obtained by emitting RF radiation or via producingelectrical current absorbed by subcutaneous tissue.

It is another object of the present invention to provide the integratedsystem as defined above, wherein application of said system increasessaid skin rejuvenation such that said skin rejuvenation increase (SRI)is greater than the sum of said SRI provided by electromagnetic pulsesincrease and said SRI provided by said deep tissue diathermy deviceincrease.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said electromagnetic pulse is atriangular shaped at frequency of 25 Hz and intensity of 20 Gauss.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said electromagnetic pulse is squareshaped at a frequency of 16 Hz, duration of about 5 milliseconds andintensity of 12 Gauss.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said system reduces side effects and/orharmful effects of said electromagnetic pulses and/or said deep tissuediathermy such that said reduction of said side effects and/or saidharmful effects is greater than the sum of said reduction of saidelectromagnetic pulses and/or said reduction of said deep tissuediathermy.

It is another object of the present invention to provide the integratedsystem as defined above 56, wherein said system additionally comprisinga control system (6) adapted to regulate said electromagnetic pulsesand/or said deep-tissue diathermy.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said system is adapted to provide adynamic magnetic field such that said electromagnetic pulses vary withtime.

It is another object of the present invention to provide the integratedsystem as defined above, wherein the shape of said electromagnetic pulseis selected in a non-limiting manner from a group consisting of squarewave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spikedwave or any other mathematical combination.

It is another object of the present invention to provide the integratedsystem as defined above, wherein the magnetic field intensity B of eachpulse applied by said pulsed electromagnetic frequency generator (2)ranges between about 0 and about 3 Tesla.

It is another object of the present invention to provide the integratedsystem as defined above, wherein the duration of each pulse applied bysaid system ranges between about 3 and about 1000 milliseconds.

It is another object of the present invention to provide the integratedsystem as defined above, wherein the frequency F applied by the pulsesof said system ranges between about 1 Hz and about 1M Hz.

It is another object of the present invention to provide the integratedsystem as defined above, wherein the energy E applied by the pulses ofsaid system ranges between about 1 and about 150 watts per pulse.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said temperature T is higher than about30 and lower than about 80 degrees.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said power supply and control system(6) monitors physical tissue parameters and changes applied heat andelectromagnetic pulses accordingly.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said power supply and control system(6) additionally comprising:

-   -   a. processing means, adapted to store in a communicable database        predetermined parameters defining (i) safe treatment parameters        and (ii) unsafe treatment parameters; said parameters are        selected from a group consisting of time t of said treatment,        temperature T of said tissue, ratio t/T, Frequency F, power P,        energy E applied by the pulses of said pulsed electromagnetic        frequency generator, depth D of said treated tissue, magnetic        field intensity B, tissue impedance, specific absorption rate        (SAR), treatment depth, superficial muscle contractions or a        combination thereof;    -   b. sensing means; adapted to sense electromagnetic radiation and        heat radiation parameters selected from a group consisting of        time t of time t of said treatment, temperature T of said        tissue, ratio t/T, Frequency F, power P, Intensity I of said        ultrasound irradiation, energy E applied by the pulses of said        pulsed electromagnetic frequency generator, depth D of said        treated tissue, magnetic field intensity B, tissue impedance,        specific absorption rate (SAR), treatment depth, superficial        muscle contractions or a combination thereof;    -   c. regulating means, adapted to allow said electromagnetic        radiation and heat radiation if said parameters are within said        safe treatment parameters and to stop the electromagnetic        radiation if the radiation parameters are in said unsafe        treatment parameters.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said power supply and control system(6) includes a mechanism for skin cooling.

It is another object of the present invention to provide the integratedsystem as defined above, especially adapted to increase skinrejuvenation in the immediate (short) range.

It is another object of the present invention to provide the integratedsystem as defined above, especially adapted to increase skinrejuvenation in the intermediate range.

It is another object of the present invention to provide the integratedsystem as defined above, especially adapted to increase skinrejuvenation in the long range.

It is another object of the present invention to provide the integratedsystem as defined above, wherein said system is especially adapted tooperate according to IEC selected from a group consisting of IEC60601-2-35, IEC 60601-2-33, IEC 60601-2-29, IEC 60601-2-9, IEC60601-2-5, IEC 60601-2-3, IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4,IEC 60601-1-3, IEC 60601-1-2, IEC 60601-1-1 or any combination thereof.

It is another object of the present invention to provide a method ofincreasing skin rejuvenation of a region of a patient's skin. The methodcomprises steps selected inter alia from:

-   -   a. obtaining an integrated system (20) adapted to increase skin        rejuvenation; said integrated system (20) comprises: at least        two electrodes (41) adapted to be placed on said region of a        patient's skin; each of said electrodes is a least partially        coiled via a coil 42;    -   b. applying heat to a subcutaneous tissue within said region up        to temperature T whilst simultaneously applying pulses of        electromagnetic field to said region;        wherein said increasing of said skin rejuvenation is greater        than the sum of said applying heat to a subcutaneous tissue        within said region and said applying pulses electromagnetic        therapy to said region

It is another object of the present invention to provide the method asdefined above, wherein said step of applying heat to a subcutaneoustissue within said region up to temperature T additionally comprisingstep of applying electrical current absorbed by subcutaneous tissue.

It is another object of the present invention to provide the method asdefined above, wherein said system reduces side effects and/or harmfuleffects of said electromagnetic pulses and/or said deep tissue diathermysuch that said reduction of said side effects and/or said harmfuleffects is greater than the sum of said reduction of saidelectromagnetic pulses and/or said reduction of said deep tissuediathermy.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of monitoring and/orcontrolling said steps of applying heat to a subcutaneous tissue withinsaid region and/or said step of applying pulsed electromagnetic therapyto said region.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of applying a dynamicmagnetic field onto said region.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of applying a triangularshaped electromagnetic pulse at frequency of 25 Hz and intensity of 20Gauss.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of applying a square shapedelectromagnetic pulse at a frequency of 16 Hz, duration of about 5milliseconds and intensity of 12 Gauss.

It is another object of the present invention to provide the method asdefined above, additionally comprising steps of

-   -   a. storing in a communicable database predetermined parameters        defining (i) safe treatment parameters and (ii) unsafe treatment        parameters; said parameters are selected from a group consisting        of time t of said treatment, temperature T of said tissue, ratio        t/T, Frequency F, power P, energy E applied by the pulses of        said pulsed electromagnetic frequency generator, depth D of said        treated tissue, magnetic field intensity B, tissue impedance,        specific absorption rate (SAR), treatment depth, superficial        muscle contractions or a combination thereof;    -   b. sensing electromagnetic radiation and heat radiation        parameters selected from a group consisting of time t of said        treatment, temperature T of said tissue, ratio t/T, Frequency F,        power P, Intensity I of said ultrasound irradiation, energy E        applied by the pulses of said pulsed electromagnetic frequency        generator, depth D of said treated tissue, magnetic field        intensity B, tissue impedance, specific absorption rate (SAR),        treatment depth, superficial muscle contractions or a        combination thereof;    -   c. allowing said electromagnetic radiation and said heat        radiation if parameters within said safe treatment parameters        and to stop the electromagnetic radiation if the radiation        parameters are in said unsafe treatment parameters.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting the shape ofsaid electromagnetic pulse is selected in a non-limiting manner from agroup consisting of square wave, a sine wave, a triangular wave,sawtooth wave, ramp waves, spiked wave or any other mathematicalcombination.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting saidtemperature T from a region of about 30 to about 80 degrees.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting the duration ofeach pulse applied by said pulsed electromagnetic frequency generator(2) to be higher than about 3 and lower than about 1000 milliseconds.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting the magneticfield intensity B of each pulse applied by said step of applying pulsedelectromagnetic therapy to said region to be higher than about 0 andlower than about 3 Tesla.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting the frequency Fapplied by the pulses applied by said step of applying pulsedelectromagnetic therapy to said region to be higher than about 1 andlower than about 1M Hz.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of selecting the energy Eapplied by said step of applying pulsed electromagnetic therapy to saidregion to be higher than about 1 and lower than about 150 watts perpulse.

It is another object of the present invention to provide the method asdefined above, wherein step of applying heat is applied for about 0.01to 60 minutes.

It is another object of the present invention to provide the method asdefined above, wherein the heat and the pulsed electromagnetic therapyare applied simultaneously, sequentially or separately.

It is another object of the present invention to provide the method asdefined above, wherein said method is repeated 1 to 100 times in eachtreatment.

It is another object of the present invention to provide the method asdefined above, wherein said treatment is repeated more than once.

It is another object of the present invention to provide the method asdefined above, wherein said step of applying heat is performed bydevices selected from a group consisting of: ultrasonic diathermy, anoptical device, electromagnetic induction, sound waves emittinginstrument, direct heat applying instrument, or from any other means ofheating subcutaneous tissue to temperature T.

It is another object of the present invention to provide the method asdefined above, especially adapted to increase skin rejuvenation in theimmediate (short) range

It is another object of the present invention to provide the method asdefined above, especially adapted to increase skin rejuvenation in theintermediate range.

It is still an object of the present invention to provide the method asdefined above, especially adapted to increase skin rejuvenation in thelong range.

It is lastly an object of the present invention to provide the method asdefined above, wherein said method is especially adapted to operateaccording to IEC selected from a group consisting of IEC 60601-2-35, IEC60601-2-33, IEC 60601-2-29, IEC 60601-2-9, IEC 60601-2-5, IEC 60601-2-3,IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601-1-3, IEC60601-1-2, IEC 60601-1-1 or any combination thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may beimplemented in practice, a few preferred embodiments will now bedescribed, by way of non-limiting example only, with reference to theaccompanying drawings, in which:

FIGS. 1A-1D schematically present a skin viability improving system(10), comprising a pulsed electromagnetic frequency generator (2) and adeep tissue diathermy device (4).

FIG. 1E is a diagram illustrating an example of electrical currentapplied by the deep tissue diathermy device (4). The current involves amaximal amplitude of 160 volts, and a frequency close to 1 Hz.

FIG. 2 schematically presents a skin viability improving system (10),comprising a pulsed electromagnetic frequency generator (2), a deeptissue diathermy device (4) and a power supply and control system (6).

FIG. 3 schematically presents square waves at a rate of 16 Hz induration of about 5 milliseconds in an intensity of 12 Gauss whichstimulate angiogenesis.

FIG. 4 schematically presents triangular wave pulses at a frequency of25 Hz and intensity of 20 Gauss which stimulate collagen production.

FIGS. 5-6 illustrate another embodiment of the skin viability improvingsystem (20).

FIGS. 7-12 schematically present the methods of improving skin viability(400-420).

FIGS. 13A-13F are pictures of one patient out of the study group treatedwith the device of the present invention.

FIGS. 14A-14F are pictures of one patient out of the first control grouptreated with the device of the present invention on the right side andRF on the left side.

FIGS. 15A-15F are pictures of one patient out of the second controlgroup treated with the device of the present invention on the right sideand PEMF on the left side.

FIGS. 16A-16F are pictures of one patient out of the third control grouptreated with the device of the present invention on the right side. Theleft side was treated with PEMF followed by RF.

DETAILED DESCRIPTION

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of said invention and sets forth the best modes contemplated by theinventor of carrying out this invention. Various modifications, however,will remain apparent to those skilled in the art, since the genericprinciples of the present invention have been defined specifically toprovide means and method for increasing the viability of the skin. Yetmore the present invention provides means and system for skin tighteningand rejuvenation.

It is one object of the present invention to disclose a device used toimprove skin viability, by a synergistic approach of deep tissuediathermy combined with application of PEMF, wherein at least twodevices of deep tissue diathermy are incorporated, one of them based onPEMF therapy. The latter improves the healing process initiated by theat least one other device of deep tissue diathermy.

The term “Pulsed Electromagnetic Fields (PEMF)” refers hereinafter in anon-limiting manner to electromagnetic radiation of differentfrequencies—ranging from static magnetic fields, through extremely lowfrequencies (ELF) to radiofrequencies (RF)—administered in pulses.

The term “Radio Frequency (RF)” refers hereinafter in a non-limitingmanner to part of the electromagnetic spectrum with frequency range ofabout 3 Hz to 300 GHz.

The term “Extremely Low Frequencies (ELF)” refers hereinafter in anon-limiting manner to part of the RF electromagnetic spectrum withfrequency range of about 3 Hz to 30 GHz

The term “collagen” refers hereinafter in a non-limiting manner to along, fibrous structural protein which is a major component of theextracellular matrix that supports most tissues and gives cellsstructure. It is responsible for skin strength and elasticity, and itsdegradation leads to wrinkles that accompany aging.

The term “epidermis” refers hereinafter in a non-limiting manner to theoutermost layer of the skin.

The term “dermis” refers hereinafter in a non-limiting manner to a layerof skin beneath the epidermis that consists of connective tissue, andcushions the body from stress and strain.

The term “deep tissue diathermy” refers hereinafter in a non-limitingmanner to a device which heats tissues beneath the epidermis.

The term “electric diathermy” refers hereinafter in a non-limitingmanner to a device which uses high frequency alternating electric ormagnetic fields, sometimes with no electrode or device contact to theskin, to induce gentle deep tissue heating by induction. For collagenfiber stimulation, typical electrical parameters may include, in a nonlimiting manner, frequency of about 1 MHz, energy of about 80 joule per1 square tissue volume, applied for about 6 seconds.

The term “ultrasonic diathermy” refers hereinafter in a non-limitingmanner to heating of tissues by ultrasound.

The term “about” refers hereinafter to a range of 25% below or above thereferred value.

The term “physical tissue parameters” refers hereinafter to parameterssuch as tissue temperature, electric current, tissue impedance, specificabsorption rate (SAR), treatment depth and superficial musclecontractions.

The term “angiogenesis” refers hereinafter to the sprouting of new bloodvessels.

The term “square wave” refers hereinafter to a non-sinusoidal waveformnamed for its square shape.

The term “triangle wave” refers hereinafter to a non-sinusoidal waveformnamed for its triangular shape.

The term “International Electrotechnical Commission Standards (IEC)60601-1” refers hereinafter to a medical electrical equipment standard.More specifically it refers to general requirements for basic safety andessential performance.

The term “IEC 60601-1-1” refers hereinafter to medical electricalequipment standard. More specifically it refers to general requirementsfor safety—Collateral standard: Safety requirements for medicalelectrical systems. The IEC 60601-1 set of standards are divided intothree distinct areas. The first area is the basic standard IEC 60601-1.This is the general requirement for all electrical medical basedproducts. The second area is the collateral standards, which coveracross the board issues such as combining into a system with otherdevices, EMC, radiation protection, and programmable electronic medicalsystems (software, firmware, etc.). The standard numbers are IEC60601-1-1, -1-2, -1-3, and -1-4 respectively. The third area is theparticular standards that deal with a specific type of medical device.The particular standards are identified as IEC 60601-2-XX where XXidentifies the particular standard number for the particular type ofmedical equipment. An example would be IEC 60601-2-3 which is theparticular standard for short-wave therapy equipment.

The term “IEC 60601-1-2” refers hereinafter to medical electricalequipment standard. More specifically it refers to general requirementsfor basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests.

The term “IEC 60601-1-3” refers hereinafter to medical electricalequipment standard. More specifically it refers to general requirementsfor basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment.

The term “IEC 60601-1-4” refers hereinafter to medical electricalequipment standard. More specifically it refers to general requirementsfor safety—Collateral Standard: Programmable electrical medical systems.

The term “IEC 60601-1-6” refers hereinafter to medical electricalequipment standard. More specifically it refers to general requirementsfor basic safety and essential performance—Collateral standard:Usability.

The term “IEC 60601-1-8” refers hereinafter to medical electricalequipment standard. More specifically it refers to general requirementsfor basic safety and essential performance—Collateral Standard: Generalrequirements, tests and guidance for alarm systems in medical electricalequipment and medical electrical systems.

The term “IEC 60601-2-3” refers hereinafter to medical electricalequipment standard. More specifically it refers to particularrequirements for the safety of short-wave therapy equipment.

The term “IEC 60601-2-5” refers hereinafter to medical electricalequipment standard. More specifically it refers to particularrequirements for the safety of ultrasonic physiotherapy equipment.

The term “IEC 60601-2-9” refers hereinafter to medical electricalequipment. More specifically it refers to particular requirements forthe safety of patient contact dosemeters used in radiotherapy withelectrically connected radiation detectors.

The term “IEC 60601-2-29” refers hereinafter to medical electricalequipment standard. More specifically it refers to particularrequirements for the basic safety and essential performance ofradiotherapy simulators.

The term “IEC 60601-2-33” refers hereinafter to medical electricalequipment standard. More specifically it refers to particularrequirements for the safety of magnetic resonance equipment for medicaldiagnosis.

The term “IEC 60601-2-35” refers hereinafter to medical electricalequipment standard. More specifically it refers to particularrequirements for the safety of blankets, pads and mattresses intendedfor heating in medical use.

The present invention relates to a physical therapeutic methods andsystems. In said systems a dynamic magnetic pulse and electromagneticheating systems are incorporated together to accomplish a physicaltherapy, epically skin tightening and rejuvenation.

The present invention provides a system adapted to increase skinrejuvenation of a region of a patient's skin. The system comprising in anon-limiting manner the following:

-   -   a. a pulsed electromagnetic field (PEMF) frequency generator (2)        for constantly providing electromagnetic pulses to said region        of a patient's skin; and,    -   b. a deep tissue diathermy device (4) applying heat to said        region of a patient's skin up to temperature T;

The system (10) is adapted for simultaneously apply heat and PEMF tosaid region of a patient's skin. Furthermore, the system increases theskin rejuvenation such that the increase is greater than the sum of theelectromagnetic pulses increase and the deep tissue diathermy.

Furthermore the system reduces side effects and/or harmful effects ofthe electromagnetic pulses and/or said deep tissue diathermy such thatsaid reduction of said side effects and/or said harmful effects isgreater than the sum of said reduction of said electromagnetic pulsesand/or said reduction of said deep tissue diathermy.

It is another object of the present invention to provide an integratedsystem (20) adapted to increase skin rejuvenation of a region of apatient's skin. The system comprising at least two electrodes adapted tobe placed on said region of a patient's skin; each of said electrodes isat least partially coiled via a coil. It is emphasized that each of saidelectrodes is adapted for both (i) providing electromagnetic pulses tosaid region of a patient's skin; and, (ii) applying heat up totemperature T to said region of a patient's skin. Furthermore, it isemphasized that all of said electrodes are adapted to simultaneouslyprovide electromagnetic pulses to said region of a patient's skin; and,apply heat up to temperature T to said region of a patient's skin.

The decrease in the side effects of the deep tissue diathermy by thehealing effect of the pulsed electromagnetic frequency therapy.

Reference is now made to FIGS. 1 a-1 d, illustrating the system 10 forincreasing skin rejuvenation. As described above, the system comprisinga pulsed electromagnetic frequency generator (2) for providingelectromagnetic pulses to the region of a patient's skin; and, a deeptissue diathermy device (4) adapted to apply heat to the region of apatient's skin up to temperature T.

It is emphasized that the system increases the skin rejuvenation suchthat the increase is greater than the sum of the electromagnetic pulsesincrease and the deep tissue diathermy.

By exposing the tissue (a region of a patient's skin) to the combinationof regulated heat and a pulsed electromagnetic filed a synergic effectof improving skin rejuvenation is obtained.

The present invention relays on 2 effects, the thermal effect and theelectromagnetic pulse effect: The thermal effect includes heating thetissue such that when the tissue is heated to a sufficiently hightemperature, tissue injury is produced. Furthermore, when heat isgenerated within the dermis, it usually causes contraction andthickening of collagen fibers. This results in an overall tightened andrejuvenated appearance of the skin.

Heat within the dermis creates a limited thermal injury. The body'snatural response to this injury is to produce collagen at the site ofthe wound. This results in firmer, thicker, more youthful skin. Usuallythe skin is heated to temperatures bellow 60 degrees for short periodsof time. The thermal effect i.e., can be produced by:

-   -   1. Optical means—by emitting light in different wavelengths        absorbed by subcutaneous tissue such that said tissue is heated;        or    -   2. Electrical means—by passing electrical current; or    -   3. Electromagnetic means—by transmitting or inducting        (electromagnetic induction) electromagnetic filed on the skin;        or    -   4. Sound waves—specifically in the ultrasound frequencies; or    -   5. Physical means—such as massage or applying warm substance        adjacent to the skin; or any combination thereof

The electromagnetic pulses (either dynamic or static) may start naturalhealing processes which usually occur in response to an injury(especially, angiogenesis, and generation of new collagen fibers via therelease of tissue growth factors).

Said electromagnetic field generates movements of charged molecules(ions) within the inter cellular fluids. This movement generates heatwhich may enhance the thermal effect discussed earlier.

It is acknowledged that healing is the process by which the cells in thebody regenerate and repair to reduce the size of a damaged area. Healingincorporates both the removal of necrotic tissue (demolition), and thereplacement of this tissue.

The replacement can happen in two ways:

-   -   1. by regeneration: the necrotic cells are replaced by the same        tissue as was originally there.    -   2. by repair: injured tissue is replaced with scar tissue.

The Pulsed Electromagnetic Fields (PEMF) applied by the system 10, asdescribed above, has no thermal effects. Said no thermal effects rely onthe tissue components and their reaction to the applied radiationcharacteristics. These effects might be due to the reaction of largecharged molecules and various frequencies and frequency harmonies,charged small ions in the cell membranes affecting the cells functionand reactions to hormones and chemical signals, charged small ions inthe extracellular space and other purely understood mechanisms.

Furthermore, applying the radiation in pulses was also found to have nonthermal effects. Yet more, only a specific combination of frequency,duty cycle and transmitted power achieve a specific tissue response.

It is now commonly accepted that electromagnetic fields (EMF) or PEMFare capable of initiating various healing processes and for treatment ofpain and edema in superficial soft tissues two decades ago. [Rosch, P.J., Markov, M. S., eds. Bioelectromagnetic Medicine, Marcel Dekker, NY,251-264].

The present invention utilizes PEMF (combined with heat applying source)for cosmetic purposes as described above. The important role of PEMF inthe specific field intensities and frequencies increases epidermalcollagen synthesis. This new formed collagen increases skin elasticityand rejuvenates its appearance. Furthermore, PEMF increases the degreeof endothelial cell tubulization and proliferation, and augmentedangiogenesis primarily by stimulating endothelial release of FGF-2,inducing paracrine and autocrine changes in the surrounding tissue.Angiogenesis, the sprouting of new blood vessels, increases blood flowto the tissue, which in turn increases oxygen and nutritional substancesdelivery to the tissue. This effect is most beneficial for an injuredtissue, promoting rapid and improved healing. The growth factor releasedfurther enhances the healing process, both in quality and time ofimprovement.

The following discloser is a more detailed description of the twocombined effects.

As disclosed earlier, the present invention discloses a system 10 whichincorporates both regulated heating means and electromagnetic pulses.

As described above, the heat can be produced by:

-   -   1. Optical means—by emitting light in different wavelengths        absorbed by subcutaneous tissue such that said tissue is heated.    -   2. Electrical means—by passing electrical current.    -   3. Electromagnetic means—by transmitting or inducting        (electromagnetic induction) electromagnetic filed on the skin.    -   4. Sound waves—specifically in the ultrasound frequencies.    -   5. Physical means—such as massage or applying warm substance        adjacent to the skin.

Reference is now made to FIGS. 1 b-1 d, illustrating the system 10according to preferred embodiment of the present invention.

According to a preferred embodiment of the present invention, the deeptissue diathermy device (4) comprises:

-   -   a. at least one electrical output device adapted to generate        electrical current; and,    -   b. at least two electrodes (41) electrically coupled to said        electrical output device and placed on said skin region.

According to said embodiment all said electrodes are adapted tosimultaneously apply said electrical current to said skin region.

FIG. 1 b illustrates system 10 in which the deep tissue diathermy device(4) comprises 4 electrodes (denoted by numerical reference 41).

FIGS. 1 c-1 d illustrate the system 10 in which the deep tissuediathermy device (4) comprises 8 electrodes (denoted by numericalreference 41).

Reference is now made to FIG. 1 e illustrating an example of electricalcurrent applied by the deep tissue diathermy device (4). The currentinvolves a maximal amplitude of 160 volts, and a frequency close to 1Hz.

According to another embodiment of the present invention, the pulsedelectromagnetic frequency generator is adapted to provide anelectromagnetic field which varies with time (dynamic magnetic field).

According to another embodiment of the present invention, the pulsedelectromagnetic frequency generator (2) which provides electromagneticpulses to the patient's skin is positioned near the treated tissue andemits a dynamic magnetic field which varies with time. The dynamicmagnetic field can vary according to any specific treatments. Forexamples, to stimulate angiogenesis, pulses at a frequency of 16 Hz,intensity of 12 Gauss and duration of about 5 milliseconds aregenerated. Alternatively, to stimulate collagen production a triangularwave pulses at a frequency of 25 Hz and intensity of 20 Gauss aregenerated.

The deep tissue diathermy device (4) is adapted to apply heat to saidregion of a patient's skin up to temperature T. According to oneembodiment of the present invention the heat is applied by passingelectrical current through the tissue. The electrical current can beperformed in one of the following three manners:

-   -   1. Through at least one electrode which is in direct physical        contact with the skin;    -   2. through at least one electrode which is not in physical        contact with the skin, and the electrical current is transferred        by induction.    -   3. through at least one antenna which passes the electrical        current to the skin via electromagnetic induction.

Reference is now made to FIG. 2, which illustrates another embodiment ofthe present invention. According to that embodiment the systemadditionally comprising a control system (6) adapted to regulate saidelectromagnetic pulses and/or said deep-tissue diathermy.

Safe treatment parameters are defined by the parameters in table 1:

TABLE 1 safe treatment parameters parameter Values Time, t 0-600 MinutesTemperature, T 25-80 Celsius Duty cycle t/T 0-100% Frequency MHz DC-10Mhz power P 0-100 Watt Energy E 0-200 Jowls magnetic field 0-10 Teslaintensity B Depth D of said 30 Millimeters treated tissue

Unsafe safe treatment parameters are defined by the parameters in table2:

TABLE 2 unsafe treatment parameters parameter Values Time, t >10 hours(none stop) Temperature, T >80 Celsius Duty cycle t/T N/A FrequencyMHz >10 MHz power P >100 Watt Energy E >200 Jowls magnetic field >10Tesla intensity B Depth D of said >30 Millimeter treated tissue

According to another embodiment the, control system (6) additionallycomprising:

-   -   (a) processing means, adapted to store in a communicable        database predetermined parameters defining (i) safe treatment        parameters and (ii) unsafe treatment parameters; said parameters        are selected from a group consisting of time t of said        treatment, temperature T of said tissue, duty cycle t/T,        Frequency F, power P, Intensity I of said ultrasound diathermy,        energy E applied by the pulses of said pulsed electromagnetic        frequency generator, treatment depth D of said treated tissue,        magnetic field intensity B, tissue impedance, specific        absorption rate (SAR), superficial muscle contractions or a        combination thereof;    -   (b) sensing means; adapted to sense electromagnetic radiation        and heat radiation parameters selected from a group consisting        of time t of time t of said treatment, temperature T of said        tissue, duty cycle t/T, Frequency F, power P, Intensity I of        said ultrasound diathermy, energy E applied by the pulses of        said pulsed electromagnetic frequency generator, depth D of said        treated tissue, magnetic field intensity B, tissue impedance,        specific absorption rate (SAR), treatment depth, superficial        muscle contractions or a combination thereof;    -   (c) regulating means, adapted to allow said pulsed        electromagnetic radiation and heat radiation if said parameters        are within said safe treatment parameters and to stop the pulsed        electromagnetic radiation if the radiation parameters are in        said unsafe treatment parameters.

According to another embodiment, the system as defined above,additionally comprising sensors for monitoring physical parametersselected form a group consisting of time t of said treatment,temperature T of said tissue, duty cycle t/T, Frequency F, power P,energy E applied by the pulses of said pulsed electromagnetic frequencygenerator, depth D of said treated tissue, magnetic field intensity B,tissue impedance, specific absorption rate (SAR), treatment depth,superficial muscle contractions or a combination thereof.

The sensors receives said parameters from the treated tissue and changesthe parameters of the pulsed electromagnetic frequency generator (2) andthe deep tissue diathermy device (4) to optimize the effect of eachcomponent and/or to augment the synergistic effect of both components,whilst avoiding harm to the tissue.

According to another embodiment of the present invention the shape ofthe electromagnetic pulse is selected in a non-limiting manner from agroup consisting of square wave, a sine wave, a triangular wave,sawtooth wave, ramp waves, spiked wave or any other mathematicalcombination.

According to another embodiment, the system as defined above is adaptedto provide electromagnetic pulse at a frequency of 16 Hz which increasesfrom 0 Gauss to 12 Gauss.

According to another embodiment, the system as defined above is adaptedto provide electromagnetic square wave pulse at a frequency of 16 Hzwhich increases from 0 Gauss to 12 Gauss.

According to another embodiment, the system as defined above is adaptedto provide short square waves at a rate of 16 Hz in duration of about 5milliseconds in an intensity of 12 Gauss. Such square wave pulses areespecially provided to stimulate angiogenesis. Reference is now made toFIG. 3, which illustrates such square wave pulse.

According to another embodiment, the system as defined above is adaptedto provide triangular wave pulses at a frequency of 25 Hz and intensityof 20 Gauss. Such pulses are especially provided to stimulate collagenproduction. Reference is now made to FIG. 4, which illustrates suchtriangular wave pulses.

According to another embodiment, the system as defined above is adaptedto provide alternating current (AC) at a frequency of 1 MHz.

According to another embodiment, the system as defined above is adaptedto provide intensity of about 80 J/cm² sec.

According to another embodiment of the present invention the magneticfield intensity B of each pulse applied by said pulsed electromagneticfrequency generator (2) ranges between about 0 and about the maxmagnetic field used in MRI devices (i.e., 3 Tesla).

According to another embodiment of the present invention, the durationof each pulse applied by said pulsed electromagnetic frequency generator(2) ranges between about 3 and about 1000 milliseconds.

According to another embodiment of the present invention, the frequencyF applied by the pulses of said pulsed electromagnetic frequencygenerator (2) ranges between about 1 and about 1M Hz.

According to another embodiment of the present invention, the energy Eapplied by the pulses of said pulsed electromagnetic frequency generator(2) ranges between about 1 and about 150 watts per pulse.

According to another embodiment of the present invention, the deeptissue diathermy device (4) is selected in a non-limiting manner from agroup consisting of electric diathermy or any device emitting RFradiation absorbed by subcutaneous tissue.

According to another embodiment of the present invention, the deeptissue diathermy device (4) is selected in a non-limiting manner from agroup consisting of an ultrasonic diathermy, an optical device,electromagnetic induction, sound waves emitting instrument, direct heatapplying instrument, or from any other means of heating subcutaneoustissue to temperature T.

According to another embodiment of the present invention, the opticaldevice is adapted to emit light in wavelengths absorbed by subcutaneoustissue such that said subcutaneous tissue is heated.

According to another embodiment of the present invention, the soundwaves emitting instrument is adapted to emit sound waves absorbed by thesubcutaneous tissue such that said subcutaneous tissue is heated.

According to another embodiment of the present invention, thetemperature T is higher than about 30 and lower than about 80 degrees.

According to another embodiment of the present invention, the powersupply and control system (6) includes a mechanism for skin cooling.

According to another embodiment of the present invention, system (10) isencased in at least one platform.

According to another embodiment of the present invention, the pulsedelectromagnetic frequency generator (2) and said deep tissue diathermydevice (4) have more than one applicator to treat more than one bodypart simultaneously.

According to another embodiment of the present invention, the pulsedelectromagnetic frequency generator (2) has electrostatic shielding.

Is should be emphasized that the system as defined in any of theembodiments produces synergic outcomes in the following three ranges:

The immediate (short) range, in the intermediate range and in the longrange.

In the immediate (short) range—the contraction and thickening ofcollagen fibers occur, which in turn results in an overall tightened andrejuvenated appearance of the skin.

In the intermediate range (i.e., about two to three weeks)—new epidermalcells and new collagen fibers are produced.

In the long range (i.e., about a month)—the cellulite is scattered.

Reference is now made to FIGS. 5-6 illustrating another system (20)according to a preferred embodiment of the present invention. Accordingto this embodiment, an integrated system (20) adapted to increase skinrejuvenation of a region of a patient's skin is provided.

The system 20 comprising at least two electrodes (41) adapted to beplaced on said region of a patient's skin; each of said electrodes is aleast partially coiled (or looped) via a coil (42).

It should be emphasized that each of said electrodes is adapted for both(i) providing electromagnetic pulses to said region of a patient's skin(via said coil); and, (ii) applying heat up to temperature T to saidregion of a patient's skin.

Furthermore, it should be emphasized that all said electrodes providesimultaneously electromagnetic pulses to said region of a patient'sskin; and, apply heat up to temperature T to said region of a patient'sskin.

The heat is provided to the skin by applying electrical current throughsaid electrodes which is absorbed by subcutaneous tissue.

FIG. 5 illustrates such a system 20 comprising 4 electrodes (denotes as41) and FIG. 6 illustrates such a system comprising 8 electrodes(denotes as 41).

It should be emphasized that the application of said system 20 increasessaid skin rejuvenation such that said skin rejuvenation increase (SRI)is greater than the sum of said SRI provided by electromagnetic pulsesincrease and said SRI provided by said deep tissue diathermy deviceincrease.

According to another embodiment of the present invention theelectromagnetic pulse in system 20 is a triangular shaped at frequencyof 25 Hz and intensity of 20 Gauss.

According to another embodiment of the present invention theelectromagnetic pulse in system 20 is square shaped at a frequency of 16Hz, duration of about 5 milliseconds and intensity of 12 Gauss.

According to another embodiment of the present invention, the system 20reduces side effects and/or harmful effects of said electromagneticpulses and/or said deep tissue diathermy such that said reduction ofsaid side effects and/or said harmful effects is greater than the sum ofsaid reduction of said electromagnetic pulses and/or said reduction ofsaid deep tissue diathermy.

According to another embodiment of the present invention, the system 20additionally comprising a control system (6) adapted to regulate saidelectromagnetic pulses and/or said deep-tissue diathermy.

According to another embodiment of the present invention, the system isadapted to provide a dynamic magnetic field such that saidelectromagnetic pulses vary with time.

According to another embodiment of the present invention, the shape ofsaid electromagnetic pulse in system 20 is selected in a non-limitingmanner from a group consisting of square wave, a sine wave, a triangularwave, sawtooth wave, ramp waves, spiked wave or any other mathematicalcombination.

According to another embodiment of the present invention, the magneticfield intensity B in system 20 of each pulse applied by said pulsedelectromagnetic frequency generator (2) ranges between about 0 and about3 Tesla.

According to another embodiment of the present invention, the durationof each pulse applied in system 20 ranges between about 3 and about 1000milliseconds.

According to another embodiment of the present invention, the frequencyF applied by the pulses of said system ranges between about 1 Hz andabout 1M Hz.

According to another embodiment of the present invention, the energy Eapplied by said system ranges between about 1 and about 150 watts perpulse.

According to another embodiment of the present invention, thetemperature T is higher than about 30 and lower than about 80 degrees.

According to another embodiment of the present invention, the powersupply and control system (6) in system (20) monitors physical tissueparameters and changes applied heat and electromagnetic pulsesaccordingly.

According to another embodiment of the present invention, the powersupply and control system (6) additionally comprising:

-   -   a. processing means, adapted to store in a communicable database        predetermined parameters defining (i) safe treatment parameters        and (ii) unsafe treatment parameters; said parameters are        selected from a group consisting of time t of said treatment,        temperature T of said tissue, ratio t/T, Frequency F, power P,        energy E applied by the pulses of said pulsed electromagnetic        frequency generator, depth D of said treated tissue, magnetic        field intensity B, tissue impedance, specific absorption rate        (SAR), treatment depth, superficial muscle contractions or a        combination thereof;    -   b. sensing means; adapted to sense electromagnetic radiation and        heat radiation parameters selected from a group consisting of        time t of time t of said treatment, temperature T of said        tissue, ratio t/T, Frequency F, power P, Intensity I of said        ultrasound irradiation, energy E applied by the pulses of said        pulsed electromagnetic frequency generator, depth D of said        treated tissue, magnetic field intensity B, tissue impedance,        specific absorption rate (SAR), treatment depth, superficial        muscle contractions or a combination thereof;    -   c. regulating means, adapted to allow said electromagnetic        radiation and heat radiation if said parameters are within said        safe treatment parameters and to stop the electromagnetic        radiation if the radiation parameters are in said unsafe        treatment parameters.

According to another embodiment of the present invention, the powersupply and control system (6) includes a mechanism for skin cooling.

According to another embodiment of the present invention, the system(20) is especially adapted to increase skin rejuvenation in theimmediate (short) range.

According to another embodiment of the present invention, the system(20) is especially adapted to increase skin rejuvenation in theintermediate range.

According to another embodiment of the present invention, the system(20) is especially adapted to increase skin rejuvenation in the longrange.

Reference is now made to FIG. 7, schematically illustrating one possiblemethod (400) of increasing skin rejuvenation of a region of a patient'sskin. The method comprising steps selected inter alia from obtaining (i)pulsed electromagnetic frequency generator; and, (ii) a deep tissuediathermy device (401); applying heat to a subcutaneous tissue withinsaid region up to temperature T (402); said temperature T is optimizedfor production of new dermal ground substance and collagen contraction.While the collagen contraction tightens the skin and conceals wrinklesimmediately, the dermal proliferation and new collagen production has alater effect. The next step is applying additional pulsedelectromagnetic field (403) which generates a healing mechanism of theheated skin, which includes growth factor and cytokines release andeventually angiogenesis.

Reference is now made to FIG. 8, which illustrates another preferredmethod of the present invention. According to this embodiment, themethod 400 additionally comprises the step of: monitoring and/orcontrolling said steps of applying heat to a subcutaneous tissue withinsaid region and/or said step of applying pulsed electromagnetic therapyto said region (404). Reference is now made to FIG. 9, schematicallyillustrating one possible method (410) of increasing skin rejuvenationof a region of a patient's skin. The method comprising steps selectedinter alia from obtaining (i) pulsed electromagnetic frequencygenerator; and, (ii) a deep tissue diathermy device (411). The next stepis applying additional pulsed electromagnetic field (412) whichgenerates a healing mechanism of the heated skin, which includes growthfactor and cytokines release and eventually angiogenesis. The final stepis applying heat to a subcutaneous tissue within said region up totemperature T (413); said temperature T is optimized for production ofnew dermal ground substance and collagen contraction. While the collagencontraction tightens the skin and conceals wrinkles immediately, thedermal proliferation and new collagen production has a later effect.

Reference is now made to FIG. 10, which illustrates another preferredmethod of the present invention. According to this embodiment, themethod 410 additionally comprises the step of: monitoring and/orcontrolling said steps of applying heat to a subcutaneous tissue withinsaid region and/or said step of applying pulsed electromagnetic therapyto said region (414). Reference is now made to FIG. 11, schematicallyillustrating one possible method (420) of increasing skin rejuvenationof a region of a patient's skin. The method comprising steps selectedinter alia from obtaining (i) pulsed electromagnetic frequencygenerator; and, (ii) a deep tissue diathermy device (421). The next stepis applying additional pulsed electromagnetic field (422) whilstsimultaneously applying heat to a subcutaneous tissue within said regionup to temperature T. The electromagnetic pulses generate a healingmechanism of the heated skin, which includes growth factor and cytokinesrelease and eventually angiogenesis. The heat applied temperature T isoptimized for production of new dermal ground substance and collagencontraction. While the collagen contraction tightens the skin andconceals wrinkles immediately, the dermal proliferation and new collagenproduction has a later effect.

Reference is now made to FIG. 12, which illustrates another preferredmethod of the present invention. According to this embodiment, themethod 420 additionally comprises the step of: monitoring and/orcontrolling said steps of applying heat to a subcutaneous tissue withinsaid region and/or said step of applying pulsed electromagnetic therapyto said region (424). According to another embodiment of the presentinvention, each of the methods as defined above additionally comprisingstep of selecting said temperature T from a region of about 30 to about80 degrees.

According to another embodiment of the present invention, each of themethods as defined above additionally comprising step of applying adynamic magnetic field onto said region.

According to another embodiment of the present invention, each of themethods as defined above additionally comprising steps of:

-   -   a. storing in a communicable database predetermined parameters        defining (i) safe treatment parameters and (ii) unsafe treatment        parameters; said parameters are selected from a group consisting        of time t of said treatment, temperature T of said tissue, duty        cycle t/T, Frequency F, power P, energy E applied by the pulses        of said pulsed electromagnetic frequency generator, depth D of        said treated tissue, magnetic field intensity B, tissue        impedance, specific absorption rate (SAR), treatment depth,        superficial muscle contractions or a combination thereof;    -   b. sensing electromagnetic radiation and heat radiation        parameters selected from a group consisting of time t of time t        of said treatment, temperature T of said tissue, duty cycle t/T,        Frequency F, power P, Intensity I of said ultrasound diathermy,        energy E applied by the pulses of said pulsed electromagnetic        frequency generator, depth D of said treated tissue, magnetic        field intensity B, tissue impedance, specific absorption rate        (SAR), treatment depth, superficial muscle contractions or a        combination thereof;    -   c. allowing said electromagnetic radiation and said heat        radiation if parameters are within said safe treatment        parameters and stopping the electromagnetic radiation if the        radiation parameters are in said unsafe treatment parameters.

According to another embodiment of the present invention, the step ofapplying heat is performed by devices selected from a group consistingof: ultrasonic diathermy, an optical device, electromagnetic induction,sound waves emitting instrument, direct heat applying instrument, orfrom any other means of heating subcutaneous tissue to temperature T.

According to another embodiment of the present invention, each of themethods as defined above additionally comprising step of selecting themagnetic field intensity B of each pulse applied by said step ofapplying pulsed electromagnetic therapy to said region to be higher thanabout 0 and lower than about max magnetic field used in MRI devices(i.e., 3 Tesla).

According to another embodiment of the present invention, each of themethods as defined above additionally comprising step of selecting thefrequency F applied by the pulses applied by said step of applyingpulsed electromagnetic therapy to said region to be higher than about 1Hz and lower than about 1 MHz.

According to another embodiment of the present invention, each of themethods as defined above additionally comprising step of selecting theenergy E applied by said step of applying pulsed electromagnetic therapyto said region to be higher than about 1 and lower than about 150 wattsper pulse.

According to another embodiment of the present invention, in each of themethods as defined above the step of applying heat lasts about 0.01 to100 minutes.

According to another embodiment of the present invention, in each of themethods as defined above the pulsed electromagnetic field lasts about0.01 to 100 minutes.

According to another embodiment of the present invention, in each of themethods as defined above the steps of applying heat and applying thepulsed electromagnetic therapy are simultaneous, sequential or separate.

According to another embodiment of the present invention, in each of themethods as defined above the method is repeated 1 to 100 times in eachtreatment.

According to another embodiment of the present invention, a typicalprotocol for the pulsed electromagnetic frequency generator (4) includesfor example, and in a non limiting manner, a preset number of 1microsecond period pulses with duty cycle of 50% and

a pause of up to 250 microsecond (in which the preset number of pulsescorrelates with energy to be supplied to skin under the treatment.)

According to another embodiment of the present invention, a typicalprotocol for the pulsed electromagnetic frequency generator (4) includesfor example, and in a non limiting manner 10 pulses, of 1 microsecondperiod with 50% duty cycle and preset pause

of up to 512 microseconds (in which the pause correlates with energy tobe supplied to skin under the treatment).

According to another embodiment of the present invention, a typicalprotocol for the pulsed electromagnetic frequency generator (4) includesfor example, and in a non limiting manner, a repetition of the previousprotocol, wherein the number of pulses administered is a multiplicationof 10.

According to another embodiment of the present invention, in each of themethods as defined above the treatment is repeated more than once.

According to another embodiment of the present invention, each of themethods as defined above additionally comprising step of selecting theshape of said electromagnetic pulse is selected in a non-limiting mannerfrom a group consisting of square wave, a sine wave, a triangular wave,sawtooth wave, ramp waves, spiked wave or any other mathematicalcombination.

It should also be appreciated that the above described description ofmethods and apparatus are to be interpreted as including apparatus forcarrying out the methods, and methods of using the apparatus of any typeas well known to a person or ordinary skill, and which need not bedescribed in detail herein for enabling a person of ordinary skill topractice the invention.

For the main embodiments of the invention, the particular selection oftype and model is not critical, though where specifically identified,this may be relevant. The present invention has been described usingdetailed descriptions of embodiments thereof that are provided by way ofexample and are not intended to limit the scope of the invention. Nolimitation, in general, or by way of words such as “may”, “should”,“preferably”, “must”, or other term denoting a degree of importance ormotivation, should be considered as a limitation on the scope of theclaims or their equivalents unless expressly present in such claim as aliteral limitation on its scope. It should be understood that featuresand steps described with respect to one embodiment may be used withother embodiments and that not all embodiments of the invention have allof the features and/or steps shown in a particular figure or describedwith respect to one of the embodiments. That is, the disclosure shouldbe considered complete from combinatorial point of view, with eachembodiment of each element considered disclosed in conjunction with eachother embodiment of each element (and indeed in various combinations ofcompatible implementations of variations in the same element).Variations of embodiments described will occur to persons of the art.Furthermore, the terms “comprise,” “include,” “have” and theirconjugates, shall mean, when used in the claims, “including but notnecessarily limited to.” Each element present in the claims in thesingular shall mean one or more element as claimed, and when an optionis provided for one or more of a group, it shall be interpreted to meanthat the claim requires only one member selected from the variousoptions, and shall not require one of each option. The abstract shallnot be interpreted as limiting on the scope of the application orclaims.

It is noted that some of the above described embodiments may describethe best mode contemplated by the inventors and therefore may includestructure, acts or details of structures and acts that may not beessential to the invention and which are described as examples.Structure and acts described herein are replaceable by equivalentsperforming the same function, even if the structure or acts aredifferent, as known in the art. Therefore, the scope of the invention islimited only by the elements and limitations as used in the claims.

EXAMPLES

Examples are given in order to prove the embodiments claimed in thepresent invention. The example, which is a clinical test, describes themanner and process of the present invention and set forth the best modecontemplated by the inventors for carrying out the invention, but arenot to be construed as limiting the invention.

Example 1

A clinical test was performed to demonstrate the synergic effect of thecombined PEMF and the deep tissue diathermy device.

The aim of the example is to evaluate the synergetic effect of thecombined technology and compare it to each technology individually.

A multi polar magnetic pulsed synthesizer which simultaneously emits RFand magnetic pulses in varying phases that homogeneously cause supranormal temperatures over the treated area and penetrates the dermis andhypodermis was used.

METHOD

The test included 40 women at the age of 42-61 years.

They were divided to 4 groups; 1 study group and 3 control groups, eachgroup included 10 clients. All participants were selected verypunctiliously according to predefined criterions which included loosenskin in the forehead, eyes and neck area.

All groups were treated for skin tightening of the face (forehead &eyes) and neck. In all groups the right side of the face and neck wastreated only by the use of combined technology and the left side of theface and neck was treated according the following:

Study group: the combined technology as well.

First control group: RF technology.

Second control group: PMF (Pulsed Magnetic Field) technology.

Third control group: PMF technology and 2 hours later RF technology.

Sessions were conduced once a week for a period of 8 weeks.

Each session lasted 40 minutes (20 minutes each side) except of thethird control group which lasted 60 minutes (right side 20 minutes andleft side 40 minutes because we used 2 different technologies).

Clinical results were collected in two paths; objective and subjective.

Objective Method

Objective method was conducted by taking photographs in order to assessthe changes in the tightness of the skin induced by the treatments.

The pictures were taken before and after treatments by the same operatorunder the same conditions. The pictures were taken while the participantsat in front of a chart with vertical and horizontal lines with thecamera placed at the same height distance and with the same lighteningconditions.

Subjective Method

Subjective method was conducted by clients' self report.

The subjective method was conducted by questions that each client had tofill after every treatment, referring the immediate results they hadnoticed on each treated side, the notice of accumulative effect, thesatisfaction of the patients from the results, sensation of thetreatments etc.

The patients received satisfaction questionnaire which included yes/noquestions and questions to be grade on 1 to 5 satisfaction scales(1—represents “Not At All” and 5 represents “Very Much”).

Additionally there were open questions adapted to enable the patientsthe ability to express any kind of feeling following the treatments.

The following questionnaire was handed to the patients after eachtreatment (except of specific questions):

Full Question Score Answer Do you see any visual Not Very changes on theright side at all much that was treated? 1 2 3 4 5 Please describe inthe “Full Answer” column. Are you satisfied from Not Very the visualchanges on at all much the right side that was 1 2 3 4 5 treated? Isthere any specific Yes/No feeling you feel on the right side that wastreated (tightness, lifting, stretched, fullness, swelled, loosen, ache,scratching)? Please describe in the “Full Answer” column. Are yousatisfied from Not Very the feeling you feel on at all much the rightside that was 1 2 3 4 5 treated? Do you see any visual Not Very changeson the left side at all much that was treated? 1 2 3 4 5 Please describein the “Full Answer” column. Are you satisfied from Not Very the visualchanges on at all much the left side that was 1 2 3 4 5 treated? Isthere any specific Yes/No feeling you feel on the left side that wastreated (tightness, lifting, stretched, fullness, swelled, loosen, ache,scratching)? Please describe in the “Full Answer” column. Are yousatisfied from Not Very the feeling you feel on at all much the leftside that was 1 2 3 4 5 treated? Answer How long did the visual onlyfrom results last on the right the second side that was treatedtreatment (Please describe in the “Full Answer” column)? Answer How longdid the visual only from results last on the left the second side thatwas treated treatment (Please describe in the “Full Answer” column)?Answer Do you feel that the results Yes/No only after on the left sidethat was the 5^(th) treated were accumulated treatment from the firsttreatment? Answer Do you feel that the results Yes/No only after on theright side that was the 5^(th) treated were accumulated treatment fromthe first treatment? Answer Do you feel that the results Yes/No afterthe 8^(th) on the left side that was treatment treated were accumulatedfrom the first treatment? Answer Do you feel that the results Yes/Noafter the 8^(th) on the right side that was treatment treated wereaccumulated from the first treatment? General comments

RESULTS

Study Group

All patients have shown immediate and highly noticeable results on bothsides, after the first treatment; the skin tightness of the face andneck increased, it was smoother and with less wrinkles

Further, after 5 treatments it was noticeable that the results wereaccumulated (based on comparison between pictures before the firsttreatment and pictures before the 5^(th) treatment). After 8 treatmentsthe skin tightness increased significantly. All clients indicated greatsatisfaction from the immediate visual results (tightness & stretched)as well as the long term results.

The average score of visual results and satisfaction on the righttreated side was 4.66 (on 1 to 5 scale) and on the left treated side theaverage score was 4.8. 100% of the clients reported that the results onboth sides remained all week along the sessions and were accumulated.

They report feeling of tightness, firm and highly comfort during thetreatment in terms of the sensation (“Feels like hot stones massage”)and expressed satisfaction from the sort time of the treatment.

Reference is now made to FIGS. 13A-13F which are pictures of one patientout of the study group treated with the device of the present invention.The pictures were taken before the treatment (see FIG. 13A for theforehead and FIG. 13B for the neck), after the first treatment (see FIG.13C for the forehead and FIG. 13D for the neck) and after the 8^(th)treatment (see FIG. 13E for the forehead and FIG. 13F for the neck).

First Control Group

All patients have shown immediate results on both sides, after the firsttreatment. However the results were more significant in terms oftightening and wrinkles fading on the right side compare to the leftside.

The average score of visual results and satisfaction on the righttreated side was 4.93 compare to the left treated side which was 4.8.

Following 5 treatment it was noticeable that the results wereaccumulated significantly on the right side in comparison to the resultson the left side which lasted only for few days. 90% of the clientsreported that the results on the right side remained all week along thefirst 5 treatments and were accumulated compare to 40% of the clientsthat reported maintenance of the results on the left side.

After 8 treatments the skin tightness increased even more on the rightside and 100% of the clients reported accumulative results compare tothe results of the left side which remained almost the same and only 50%of the clients reported maintenance of the results.

Both clients indicated higher satisfaction from the immediate and longterm results on the right side compare to the left side. No differencebetween both treated sides in terms of comfort was expressed.

Reference is now made to FIGS. 14A-14F which are pictures of one patientout of the first control group treated with the device of the presentinvention on the right side and RF on the left side. The pictures weretaken before the treatment (see FIG. 14A for the forehead and FIG. 14Bfor the neck), after the first treatment (see FIG. 14C for the foreheadand FIG. 14D for the neck) and after the 8^(th) treatment (see FIG. 14Efor the forehead and FIG. 14F for the neck).

Second Control Group

All patients have shown immediate and very noticeable results (skintightening and wrinkles fading) on the right side after the firsttreatment and the results have improved after the 5^(th) and the 8^(th)treatment.

The average score of visual results and satisfaction on the righttreated side was 5.00 compare to the left treated side which was only1.9.

It should be pointed out that on the left side they didn't show anyresults in terms of skin tightness along the treatments, although afterthe 4^(th) treatment the skin showed some improvement (it looked moreglowing and nourished).

All clients indicated high satisfaction from the immediate and long termresults on the right side. 100% of the clients reported that the resultson the right side remained all week along the first 5 treatments andwere accumulated (and up to the 8^(th) treatment) compare to 10% of theclients that reported maintenance of the results on the left side.

As for the left side, they reported after the 5^(th) treatmentsatisfaction from the improved skin's condition and look, although theyexpressed some disappointment from not having results in terms of skintightening. They reported high comfort in terms of the treatmentsensation during the treatment of both sides.

Reference is now made to FIGS. 15A-15F which are pictures of one patientout of the second control group treated with the device of the presentinvention on the right side and PEMF on the left side. The pictures weretaken before the treatment (see FIG. 15A for the forehead and FIG. 15Bfor the neck), after the first treatment (see FIG. 15C for the foreheadand FIG. 15D for the neck) and after the 8^(th) treatment (see FIG. 15Efor the forehead and FIG. 15F for the neck).

Third Control Group

All patients have shown on the right side very noticeable immediate andaccumulative results (skin tightening and wrinkles fading).

The satisfaction was very high.

On the left side visual results are seen; the immediate results weresimilar to the right side, however the accumulative results were lesssignificant and noticeable compare with the left side.

The average score of visual results and satisfaction on the righttreated side was 4.83 compare to the left treated side which was only2.36.

90% of the clients reported that the results on the right side remainedall week along the first 5 treatments (and up to the 8^(th) treatment)and were accumulated.

Only 30% of the clients reported maintenance of the results on the leftside. In term of satisfaction the clients expressed inconvenient due tothe long duration of the treatment.

Reference is now made to FIGS. 16A-16F which are pictures of one patientout of the third control group treated with the device of the presentinvention on the right side. The left side was treated with PEMFfollowed by RF. The pictures were taken before the treatment (see FIG.16A for the forehead and FIG. 16B for the neck), after the firsttreatment (see FIG. 16C for the forehead and FIG. 16D for the neck) andafter the 8^(th) treatment (see FIG. 16E for the forehead and FIG. 16Ffor the neck).

The following tables (tables 3 and 4) summaries the results:

TABLE 3 average score (1 to 5 scale) of all participant in each groupfollowing all the treatments: Question Study group Control 1 Control 2Control 3 Do you see any 4.7 4.9 5 4.9 visual changes on the right sidethat was treated? Are you setisfied 4.7 5 5 4.8 from the visual changeson the right side that was treated? Are you setisfied 4.6 4.9 5 4.8 fromthe feeling you feel on the right side that was treated? Do you see anyvisual 4.9 2.5 1.9 2.4 changes on the left side that was treated? Areyou setisfied 4.8 2.6 2 2.3 from the visual changes on the left sidethat was treated? Are you setisfied 4.7 2.4 1.8 2.4 from the feeling youfeel on the left side that was treated?

TABLE 4 results of “Yes/No” Questions of all the patients in each groupfollowing all the treatments Study group Control 1 Control 2 Control 3Question Yes No Yes No Yes No Yes No Is there any specific feeling you 80% 20%  90% 10% 100%  0% 80% 20% feel on the right side that wastreated? (tightness, lifting stretched, fullness, swelled, loosen, ache,scratching)? Is there any specific feeling you  90% 10%  60% 40%  40%60% 50% 50% feel on the left side that was treated? (tightness, liftingstretched, fullness, swelled, loosen, ache, scratching)? Answer onlyafter the 5th treatment: Do you feel that the results on 100% 0% 40% 60% 10% 90% 30% 70% the left side that was treated were accumulated fromthe first treatment? Do you feel that the results on 100% 0% 90% 10%100%  0% 90% 10% the right side that was treated were accumulated fromthe first treatment? Answer only after the 8th treatment: Do you feelthat the results on 100% 0% 50% 50%  20% 80% 30% 70% the left side thatwas treated were accumulated from the first treatment? Do you feel thatthe results on 100% 0% 100%   0% 100%  0% 100%   0% the right side thatwas treated were accumulated from the first treatment?

CONCLUSIONS

The synergetic effect of the device of the present invention clearlyshows objectively and subjectively superior results when compare to thetreatments in which only RF, or only PEMF were used.

It has shown that clients who were treated on the left side with PEMFtechnology had a much clearer difference between both sides. This isprobably since they have not seen any tightness effect on the left side.

In addition it was shown that clients that were treated with the deviceof the present invention on both sides felt significant changes alongthe treatment. Yet more, it was harder for them to see the differencebetween both sides since both sides were treated with the device of thepresent invention and both sides had improved in the same way. 80%-100%out of all 40 participants answered “Yes” regarding questions concerningthe tightness of the skin and the accumulative results on the righttreated area. Only 10%-50% that were treated on the left side with othertechnology answered “Yes” regarding questions concerning the tightnessof the skin and the accumulative results.

The results with the combined technology (the device provided by thepresent invention) were immediate and they maintained and improved fromone treatment to the other. Immediate skin tightening has been seen dueto the change of collagen fibers formation (they become shorter andthicker and as a result harder) induced by thermal technique of the RF.

Long lasting results has been seen due to the increase of new collagenfibers synthesis by using thermal (RF) and non-thermal (PEMF)technologies induced by the device of the present invention enables theformation change of greater amount of collagen fibers and as a resultscreated physiological buttress that enabled better structural support ofthe skin.

The assets of the device of the present invention to the medical fieldare:

-   -   Synergistic effect that stimulates dermal fibroblasts which        produce new collagen, elastic and reticular fibers by using        different mechanisms (Heating & non heating);    -   Changing the form of a greater amount of collagen fiber by        making them shorter and thicker; and,    -   Angiogenesis—increasing the formation of new small blood        vessels.

The invention claimed is:
 1. An integrated system for increasing skinrejuvenation of a region of a patient's skin, said system comprising: atleast two electrodes adapted to be placed on said region of saidpatient's skin; an electromagnetic field generator adapted to generateelectromagnetic field pulses; a control system; and, at least twohelical coils; wherein: each of said electrodes is encircled by at leastone of said at least two helical coils; none of said electrodes isconfigured to penetrate said skin; each of said electrodes is configuredto provide electromagnetic pulses to said region of a patient's skin,said electromagnetic pulses provided to said electrode by said helicalcoils; each of said electrodes is configured to apply heat up to atemperature T in a range of 25 degrees Celsius to 80 degrees Celsius;said control system is adapted to control said electromagnetic fieldgenerator and application of said heat by said electrodes; and, all ofsaid electrodes are adapted to simultaneously provide saidelectromagnetic pulses to said region of a patient's skin and to applysaid heat to said region of a patient's skin.
 2. The system according toclaim 1, wherein said heat applied to said region of a patient's skin isobtained by emitting RF radiation or via producing electrical currentabsorbed by subcutaneous tissue.
 3. The system according to claim 1,wherein said electromagnetic pulses are selected from a triangularshaped waveform with a frequency of 25 Hz and intensity of 20 Gauss or asquare shaped waveform with a frequency of 16 Hz, duration of about 5milliseconds and intensity of 12 Gauss.
 4. The system according to claim1, wherein said system is adapted to provide a dynamic magnetic fieldsuch that said electromagnetic pulses vary with time.
 5. The systemaccording to claim 1, wherein each of said electromagnetic pulses has ashape selected from the group consisting of a square wave, a sine wave,a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and anycombination thereof.
 6. The system according to claim 1, wherein saidcontrol system (6) monitors physical tissue parameters and changes saidapplied heat and said electromagnetic pulses accordingly.
 7. The systemaccording to claim 1, wherein a magnetic field intensity B of each pulseapplied by said pulsed electromagnetic frequency generator (2) rangesbetween about 0 and about 3 Tesla.
 8. The system according to claim 1,wherein a duration of each pulse applied by said system ranges betweenabout 3 and about 1000 milliseconds.
 9. The system according to claim 1,wherein a frequency F applied by the pulses of said system rangesbetween about 1 Hz and about 1M Hz.
 10. The system according to claim 1,wherein an energy E applied by the pulses of said system ranges betweenabout 1 and about 150 watts per pulse.